FDA Chief Scott Gottlieb to Resign

Scott Gottlieb
Scotty We Hardly Knew Ye!
By Dan Flynn

Scott Gottlieb Scotty We Hardly Knew Ye! By Dan Flynn

Trump in a post on Twitter said Gottlieb "has done an absolutely terrific job" and that "his talents will be greatly missed". The official said Gottlieb, 46, who has been commuting to Washington from CT, wanted to spend more time with his wife and three daughters. Since assuming office on May 11, 2017, Gottlieb has been commuting from his home in Westport, CT, to FDA headquarters in Silver Spring, MD. "It seemed like he was still kind of mid-stride. I wish Scott and his family the best".

Another person familiar with his thinking said Gottlieb had also been frustrated by the government shutdown that shuttered numerous agency's activities for about a month. Gottlieb also announced he would seek a ban on menthol cigarettes, a move welcomed by public health advocates. "There's no intrigue here", he said in a statement.

"We've taken notable enforcement actions to confront bad actors that put Americans at risk", Gottlieb wrote, highlighting agency crackdowns on bogus stem-cell therapies as well as unsafe medical devices and dietary supplements.

Analysts also highlighted that the tobacco products division of the FDA was "clearly moving down a path toward greater restrictions", particularly in regard to combustible products (i.e. normal cigarettes) and flavoured e-cigarettes.

Gottlieb also targeted the growing youth use of e-cigarettes.

"He made proposals that were unprecedented in their breadth, scope and, if they were adopted, likely impact", said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

Under Dr Gottlieb, the FDA proposed a ban on the sale of fruit- and candy-flavored electronic cigarettes in convenience stores and gas stations. "When so many of these policies are at such a crucial juncture, it is hard to imagine why he would depart now". Azar lauded Gottlieb's record on drug approvals, opioids and tobacco.

Dr Gottlieb ran into fierce opposition from anti-regulation groups, such as Americans for Tax Reform, and former FDA officials, who said the agency's regulatory efforts would destroy thousands of jobs. If fully implemented, those key measures would significantly improve the health of our nation and reduce cancer death.

Departure of both Gottlieb and Christl from the agency in short succession raises questions about how ongoing initiatives related to biosimilars will be carried forward under new leadership.

Throughout his tenure at the FDA, Gottlieb has been vocal about the importance of creating a sustainable biosimilars market in Untied States. "He had a good real-world perspective he brought in". Speaking remotely in a fireside chat at the JP Morgan Healthcare Conference in January, he said the objective would be to facilitate more generic drug launches, not just approvals.

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